FDA-Device2026-10-07Class IIMISBRANDING
ASP Global disposable tourniquet cuff recalled for incorrect expiration date labeling
What this means
ASP Global's disposable tourniquet cuffs (Model ASP-564010), manufactured between September 2016 and March 2023, are labeled with a 10-year shelf life. The actual validated shelf life is 5 years. This means some cuffs may have been used past their safe sterility window.
- Check for Model ASP-564010 tourniquet cuffs manufactured between September 2016 and March 2023.
- Review the expiration date on the package. If the cuff expired more than 5 years after manufacture, do not use it.
- Contact your medical device supplier or ASP Global for instructions on returning or replacing affected units.
- Consult your facility's device management protocol for proper handling of recalled sterile devices.
The agency's original wording
Hazard
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.
Affected count
34550
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0043-2027More ASP Global recalls
- FDA-Device2026-10-07ASP Global disposable tourniquet cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07ASP Global MPR tourniquet cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07Expressaire disposable tourniquet cuffs recalled for incorrect expiration dating
- FDA-Device2026-10-07Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the opera
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